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临床试验/NCT06781684
NCT06781684进行中(未招募)不适用

Ulnar Shaft Fracture Fixation by Antegrade Versus Retrograde Intramedullary k Wires in Children;A Comparative Study

Sohag University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
The duration of complete union of the bone in every group

研究概览

简要总结

This study is made to see and evaluate the outcomes of treating and fixing ulnar shaft fracture in children by antegrade versus retrograde intramedullary k wires

详细描述

This study is made on children with ulnar shaft fracture and treating their fracture by intramedullary k wires ,dividing them into two groups ,one of them the child ulnar fracture is reduced and fixed by intramedullary antegrade k wire and the other group the fracture is reduced and fixed by retrograde k wire ,and compare the functional, clinical and radiological outcomes between the two groups

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
4 Years 至 15 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Pediatric patient
  • •aging from 4 to 15 years old
  • •diaphyseal ulnar fracture
  • •either isolated or combined with radius fracture (both bone).

排除标准

  • •Segmental fractures
  • •Montaggia variants
  • •Gelliazzi fracture
  • •Fractures associated with radial head fracture - Compound fractures
  • •Fractures with neurovascular affection

研究组 & 干预措施

Antegrade intramedullary k wire group

Active Comparator

k wire entry point is from the olecranon towards the hand before the distal ulnar styloid

干预措施: ulna shaft fracture fixation in children by intramedullary k wire (Procedure)

Retrograde intramedullary k wire group

Active Comparator

k wire entry point is from the distal ulnar styloid towards the olecranon

干预措施: ulna shaft fracture fixation in children by intramedullary k wire (Procedure)

结局指标

主要结局

The duration of complete union of the bone in every group

时间窗: The evaluation is done at 2,4,6 and 12 weeks and 3 months

Each patient is evaluated radiologically after fixing the fracture by x-ray AP and lateral views after 2 week ,4 ,6 ,12 weeks and 3 months to see the time each one taking to complete union . -Also clinical and functional evaluation of every patient and timing of ability to use his forearm , ability to do supination and pronation of the forearm , flexion and extension of the elbow and wrist , ability to do ulnar deviation at the level of the wrist and degree of pain and apprehension with each movement ,Degree of pain and tenderness in the fracture site and time taking to complete disappearing of pain and tenderness ,degree of stiffness and need to physiotherapy ,these data is collected from each patient at the time of follow up in the outpatient clinic and recorded for everyone in each group.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Ahmed Ali

Orthopedic Resident at sohag university hospital

Sohag University

研究点 (1)

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